INCLUNOX HP SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ENOXAPARIN SODIUM

Saatavilla:

SANDOZ CANADA INCORPORATED

ATC-koodi:

B01AB05

INN (Kansainvälinen yleisnimi):

ENOXAPARIN

Annos:

150MG

Lääkemuoto:

SOLUTION

Koostumus:

ENOXAPARIN SODIUM 150MG

Antoreitti:

INTRAVENOUS

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

HEPARINS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0131860002; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2020-11-05

Valmisteyhteenveto

_Inclunox _
_Page 1 of 73_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
INCLUNOX
®
Enoxaparin sodium solution for injection, 100 mg/mL
30 mg/0.3 mL
40 mg/0.4 mL
60 mg/0.6 mL
80 mg/0.8 mL
100 mg/mL
(Subcutaneous or Intravenous Use Only)
Pr
INCLUNOX
® HP
Enoxaparin sodium solution for injection, 150 mg/mL (High Potency)
120 mg/0.8 mL
150 mg/mL
(Subcutaneous or Intravenous Use Only)
Anticoagulant/Antithrombotic Agent
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, Quebec
J4B 1E6
Date of Initial Approval:
November 5, 2020
Submission Control No: 233987
_ _
_Inclunox _
_Page 2 of 73_
TABLE OF CONTENTS
TABLE OF CONTENTS ..............................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION ............................................................4
1
INDICATIONS
....................................................................................................................4
Pediatrics
..............................................................................................................................4
Geriatrics
..............................................................................................................................4
2
CONTRAINDICATIONS ..................................................................................................5
3
DOSAGE AND ADMINISTRATION ...............................................................................5
3.1
Dosing Considerations
...............................................................................................5
3.2
Recommended Dose and Dosage Adjustment
...........................................................5
3.3
Administration
...........................................................................................................8
3.4
Missed Dose
.............................................................................................................10
4
OVERDOSAGE ........................................................